Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD

Sponsor

Federal University of São Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT00684853

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the association of bevacizumab and PDT is safety and effective in the treatment of exudative AMD

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration	Drug: bevacizumab Drug: vetaporfin	Phase 2

Detailed Description

Exudative AMD is the leader of blind in people more than 60 years. The best treatment for this disease today are monthly injections of anti-VEGF in the vitreous cavity which increase the chance to get endophthalmites.

The participants of this study will be randomized in 1:1 ration to one of the two study groups: single therapy of bevacizumab (3 injections in 3 months) or association of bevacizumab (3 injections in 3 months) and full fluence of PDT (single at the baseline). All bevacizumab injection will contain 1.25g of the drug and will be administrate every month for 3 continuos months.

After randomization, participants will return to the clinic approximately every four weeks for 4 months for study assessments and possible re-treatment (if is necessary). Participants will return to the clinic at week 20 for a final study assessment. Study assessments include: visual acuity, optical coherence tomography and fundus photography.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Intravitreal Bevacizumab Combined With PDT (Full Fluence) Versus Bevacizumab to Treat Exudative Age-Related Macular Degeneration

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Drug: bevacizumab 1.25 mg of bevacizumab intravitreal Drug: vetaporfin full fluence of vetaporfin
Active Comparator: 2	Drug: vetaporfin full fluence of vetaporfin

Arm

Intervention/Treatment

Active Comparator: 1

Drug: bevacizumab

1.25 mg of bevacizumab intravitreal

Drug: vetaporfin

full fluence of vetaporfin

Active Comparator: 2

Drug: vetaporfin

full fluence of vetaporfin

Outcome Measures

Primary Outcome Measures

The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to 4 months [4]

Secondary Outcome Measures

The overall probability of re-injection [4]
Proportion of participants with reduction in retinal thickening in the center subfield (i.e., thickness > 200 microns) of ³50% and of at least 50 microns from baseline [4]
Mean change in area of leakage, CNV and lesion by the FA and ICG [4]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

more or iqual 50 years old
male or female
Choroidal neovascularization sub or just foveal the fovea secondary to AMD (Predominantly Classic, Minimally Classic, and Occult lesions acceptable)
Greatest linear dimension (GLD) of entire lesion < 5400 µm (no reading center confirmation required)
ETDRS best corrected visual acuity of 20/40 - 20/320 (73 - 24 letter score)
Total area of lesion must < 9 MPS DA